Cleared Traditional

CHEMO MINI SPIKE PLUS

K983794 · B. Braun of America, Inc. · General Hospital
Mar 1999
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K983794 is an FDA 510(k) clearance for the CHEMO MINI SPIKE PLUS, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by B. Braun of America, Inc. (Allentown, US). The FDA issued a Cleared decision on March 23, 1999, 147 days after receiving the submission on October 27, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K983794 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1998
Decision Date March 23, 1999
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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